Quality Control Microbiology Specialist
Job Location:
Job Location:
Madison, OH - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
3 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
About eGenesis
eGenesis is aclinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Companys proprietary genome engineering platform enables extensive multiplex gene edits to remove key biological barriers add protective human transgenes and inactivate endogenous retroviruses. EGEN-2784 agenetically engineered porcine kidney is the Companys lead program and is currently being evaluated in amulti-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge MA.
POSITION SUMMARY
eGenesis is seeking an innovative QC Microbiology Specialist to lead and provide the technical and strategic oversight of eGenesiss environmental monitoring this position you will be responsible for hands-on environmental monitoring sampling testing reporting and trending of eGenesis GMP manufacturing facilities in Rensselaer IN. You will ensure activities are executed in a cGMP compliant manner and have the opportunity to work collaboratively on implementation and maintenance of our contamination control program. The ideal candidate will be independently motivated a strong communicator and demonstrate proficiency in regulatory compliance. This position will be in the Greater Madison Area in Wisconsin.
PRIMARY RESPONSIBILITIES
- Coordinate the environmental monitoring (EM) program at both eGenesis manufacturing facilities ensuring the collection transport and processing of air and surface samples.
- Manage the schedule for all routine and non-routine monitoring activities internally and with external contract laboratory.
- Perform environmental monitoring sample collection (nonviable viable and surface) as well as providing guidance and training on procedures to additional team members.
- Keep complete and accurate documentation in electronic test methods.
- Review and trend environmental monitoring data.
- Support EM and laboratory deviations. Identify and implement corrective actions to prevent reoccurrence.
- Author review and/or approve data SOPs COAs protocols reports deviations and other quality records.
- Work collaboratively with QC contamination control representative and work cross functionally to maintain and enhance cleaning/disinfection program material/equipment and gowning programs as applicable.
- This position will require some travel (20% of time) between manufacturing sites in Wisconsin and Indiana but primary location will be in Wisconsin.
BASIC QUALIFICATIONS
- B.S./M.S. in Life Sciences or related field with 0-3 years of experience in GMP QC Laboratory.
- Proficient in microbiology methods (plate enumeration growth promotion microbial ID etc.) and aseptic technique needed to perform EM in a GMP environment.
- Strong knowledge of US and EU cGMP regulations/guidance.
- The ability to work and lead in a fast-paced environment manage priorities and maintain timelines for multiple projects is essential.
- Effective communication skills both verbal and written at all levels and across various functions.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
IC
